DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant's arguments filed 4/17/2026 have been fully considered.
Regarding the objection to the drawings, the amended drawings have been accepted and therefore the objection is withdrawn.
Regarding the objections to claim 4 and 7, Applicant’s arguments are convincing. The amendments to the claims overcome the prior art of record and the objections are therefore withdrawn.
Regarding the rejections under 112(b), the examiner agrees that the amendment to claim 2 overcomes the antecedent basis rejection, however, a claim objection is made below due to lack of clarity of the claim.
The amendments to claims 11, 13,1 4 overcome the 112 rejections and the rejections are therefore withdrawn.
Regarding the rejections of claims 1-5, 7 under 103, Applicant’s argument have been considered and are not convincing. Claim 1 have been amended to further limit the barrel, however the barrel is recited only functionally in claim 1 and therefore further limitations drawn to the barrel are not positively recited in the claim. Therefore, the amendments to claim 1 do not distinguish over the prior art of record.
Regarding claim 8, the examiner agrees that the cited prior art fails to disclose the sealing element having a laterally outermost surface configured to be directly engaged with a retaining ring to sealingly isolate the stopper from the medicinal fluid in the barrel when the stopper is in the storage position. However, the examiner does not find 112(a) support for this limitation in the disclosure as described below.
Claim Objections
Claim 2 is objected to because of the following informalities: claim 2 recites “the sealing element comprises the polymeric material chemically inert to the medicinal fluid”. This amendment clarifies that “the polymeric material” is the same material introduced in claim 1, however now the claim does not read clearly. If the claim is intended to further limit the polymeric material, the examiner suggest – wherein the polymeric material is chemically inert to the medicinal fluid to be disposed in the barrel – or similar.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 8-14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 8 calls for the laterally outermost surface of the sealing element to be configured to be directly engaged with a retaining ring to sealingly isolate the stopper for the medicinal fluid in the barrel when the stopper is in the storage position. The disclosure does not describe this function of the retaining ring. It is presumed that the claimed retaining ring corresponds to retaining ring 205 seen in fig. 4B. In the storage position, this retaining ring does not appear to directly engage the laterally outermost surface of the sealing element as the entire sealing element is located proximal to the retaining ring.
Claims 9-14 inherit the deficiencies of claim 8.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-7 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “A stopper assembly configured to be disposed in a barrel of an injection device…”. this preamble is interpreted to recite a stopper wherein the barrel is recited only functionally. Further limitations of the claim are drawn to specific structures of the barrel. It is not clear if applicant intends to positively recited the barrel since it appears the barrel limitations have been included to distinguish the claim over the prior art of record. However, the claim as written merely further limits a functional recitation and the barrel and additional structures thereof are not interpreted to be part of the scope of the claim.
Claims 2-7 inherit the deficiencies of claim 1.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-5, 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beebe (US 6,676,642) in view of Fischer (US 4,986,820).
Regarding claim 1, Beebe discloses a stopper assembly configured to be disposed in a barrel of an injection device containing a medicinal fluid (fig. 4), the stopper assembly comprising a stopper 20 having a laterally outermost surface configured to be directly engaged with an inner surface of the barrel (fig. 4 annotated below), and a sealing element 8 coupled to and axially distal relative to the stopper in the barrel (fig. 4), the sealing element having a laterally outermost surface configured to be directly engaged with the inner surface of the barrel (fig. 4 annotated below) and to sealingly isolate the stopper from the medicinal fluid in the barrel (fig. 4; col. 3, lines 7-11: problem to be solved is the piston deforming and allowing fluid to contact the portion proximal to the piston and therefore in the disclosed configuration, the piston isolates the stopper from the fluid). The limitation “configured to be disposed in a barrel” is interpreted to be an intended use limitation wherein the barrel is not positively recited. Therefore, the claim limitations further drawn to the barrel are interpreted to be further limitations of the intended use. The stopper discussed above is capable of being used with a barrel having the recited structure.
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Claim 1 further calls for the sealing element to be made of a rigid or semi-rigid polymeric material that is not axially compressible. Fischer teaches a stopper assembly wherein the sealing element is formed from a relatively noncompressible material such as polypropylene or polyethylene that allows preloading of the syringe with a liquid medicament without the sealing means leaking or reacting with the medicament (col. 4, lines 19-33). It would have been obvious to one or ordinary skill in the art before the effective filing date of the claimed invention to modify the sealing element of Beebe to be formed from a material such a polypropylene or polyethylene as taught by Fischer to provide a material that has an effective sealing without leaking or reacting with the medication. This material is semi-rigid and not axially compressible.
Regarding claim 2, Fischer teaches that the polymeric material is chemically inert to the medicinal fluid (col. 4, lines 19-33; col. 6, lines 23-31) as discussed above with regard to claim 1.
Regarding claim 3, Beebe discloses that the sealing element has a distal portion and a proximal portion, the distal portion having a maximum lateral dimension greater than a maximum lateral dimension of the proximal portion (see fig. 4 annotated below).
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Regarding claim 4, Beebe discloses that the stopper has a distal surface and a proximal surface, the stopper comprises a cavity extending into the stopper from the distal surface, and the proximal portion of the sealing element is disposed in the cavity of the stopper (see fig. 4 annotated below).
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Regarding claim 5, Beebe discloses that the cavity comprises a laterally-extending groove and the proximal potion of the sealing element comprises a laterally-extending projection, the projection received in and engaged with the groove to couple the stopper to the sealing element (see fig. 4 annotated below).
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Regarding claim 7, Beebe discloses that the distal portion of the sealing element is disc-shaped (fig. 4).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beebe in view of Fischer as applied to claims 1 above, and further in view of Sudo et al (US 6,090,081).
Claim 6 differs from the teachings above in calling for the laterally outermost surface of the sealing element to have a surface roughness in a range from about 0.012 µm to 0.10 µm. Sudo teaches a syringe having a sealing element wherein the sealing element has an outermost surface having a surface roughness of 0.05 µm which is within the claimed range, the surface roughness providing a high sealing property and slidable property (col. 5, lines 18-27) thereby ensuring that the syringe does not leak during storage and also does require excessive force to deliver the fluid from the syringe. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sealing element of Beebe to have a surface roughness of 0.05 µm as taught by Sudo to provide good sealing properties and good sliding properties.
Allowable Subject Matter
Claims 8-14 are allowable over the prior art of record, but are subject to a 112(a) rejection above. Should the claims be amended to address the 112(a) rejection, the claims will be reconsidered with regard to the prior art.
Claims 15-16 are allowed.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA A BOUCHELLE whose telephone number is (571)272-2125. The examiner can normally be reached Mon-Fri 8:00-5:00 CST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at 571-272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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LAURA A. BOUCHELLE
Primary Examiner
Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783
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